The surface of female vaginal mucous is suitable for microorganisms such as bacteria, fungi, etc. to inhabit. The dominant bacteria inhabited on healthy vaginal mucous surface are large Gram-positive rods, usually called “vaginal normal flora”. Most of these large Gram-positive rods belong to lactobacilli. They are capable of producing acids by metabolizing substances such as glycogen in vaginal mucous epithelial cells so as to maintain the vaginal acidity within a pH value range from 3.5 to 4.5, inhibit pathogens, and resist infection. Undoubtedly, they play a very important role in the health of female genital tract. The abnormal changes of the vaginal flora and acidity usually cause a series of disorders including genital tract infections.
Many factors may disturb vaginal flora and vaginal acidity. Thereby, the large Gram-positive rods would be reduced while a variety of Gram-negative rods and cocci increase and dominate. The pH value of vaginal secretion would be elevated to 4.8, even 5.4 or higher. Complaints such as vulvodynia, pruritus vulvae, algopareunia, abnormal leucorrhea with fishy smell, etc. would be common in these individuals. The vaginal resistance of the patient against infections usually decreases so as to increase the risk to STD and HIV infections. The abnormal changes of vaginal flora may also induce infections in urinary system, and is especially harmful to the health of pregnant women and fetus, including serious consequences such as abortion, premature delivery, intrauterine growth retardation of fetus, etc.
Among various vaginal infections, Candidal vaginitis, Bacterial vaginosis (BV), Lactobacillosis (LB) and Cytolytic vaginosis (CV) are four common diseases. However, their pathogenesises are all related to the abnormality of vaginal flora and vaginal acidity.
Candidal vaginitis is commonly deemed as an endogenous infection. It usually relates to the overgrowth of monilia and the toxin produced thereby in acidic microenvironment, which is formed by acids produced by lactobacilli in vagina. The monilial hypha or spore could be found in the patient's vaginal secretion. The pH value of vaginal secretion usually is lower than 4.5. The clinical symptoms include pruritus vulvae, vulvar causalgia, odynuria, algopareunia, etc. The symptoms are usually most serious before menstruation and alleviated during and after menstruation. Therapeutic methods include the administration of various antifungal agents or antibiotics, such as ketoconazole, nystatin, etc.
Lactobacillosis and Cytolytic vaginosis similarly relate to the over-production of acids by vaginal lactobacilli. Large and long Gram-positive rods are observable in vaginal secretion, while monilial hypha or spore could not be found. Usually, the vaginal acidity of patient is over-high, and the pH value of vaginal secretion is below 4.0 in general. The clinical symptoms are similar with those of Candidal vaginitis, including pruritus vulvae, vulvar causalgia, odynuria, algopareunia, etc., which usually are most serious before menstruation and are obviously alleviated during and after menstruation, as periodic episode. Therapeutic methods mainly include the bidet cleaning with alkali solution of sodium bicarbonate to neutralize the high acidity of vaginal secretion, and the administration of antibiotic Augmentin (Amoxicillin+Clavulanic acid) to inhibit lactobacilli.
Bacterial vaginosis is also an endogenous infection, but its pathogenesis is different from those of the aforementioned diseases. The main reasons are the reduction of vaginal lactobacilli and the reduction of vaginal acidity, which result in the overgrowth of many microorganisms including anaerobic bacteria, etc. and cause various disorders, so that Bacterial vaginosis is also called as “polymicrobial syndrome”. The pH value of vaginal secretion usually is higher than 4.5, and the clinical symptoms include pruritus, homogeneous and fishy smell leucorrhea, etc., which are serious after menstruation and are alleviated before menstruation. Internationally, the medicine for treatment of this disease is primarily selected from antibacterial agents such as metronidazole, clindamycin, etc., which exhibit strong effect on anaerobic bacteria.
In sum, although Candidal vaginitis, Lactobacillosis, Cytolytic vaginosis, and Bacterial vaginosis are different diseases in aspects of etiology, pathology, diagnosis and treatment, they all relate to vaginal flora and vaginal acidity: either as Lactobacillosis, Cytolytic vaginosis and Candidal vaginitis caused by the over-production of acids by lactobacilli, or as Bacterial vaginosis caused by the reduction of vaginal lactobacilli and the reduction of vaginal acidity. It can be seen that the abnormality of vaginal flora and vaginal acidity plays a very important roles in the occurrence and development of these vaginal diseases.
However, the current methods for treatment of these diseases mainly aim at the pathogens that cause the diseases. For example, the treatment of Candidal vaginitis is conducted by inhibiting and/or killing fungi with antifungal agents selected from fluconazol, nystatin, etc. The treatment of Bacterial vaginosis is conducted by directly killing anaerobic bacteria with antibacterial agents selected from metronidazole, etc. The treatment of Lactobacillosis and Cytolytic vaginosis is conducted by inhibiting lactobacilli with antibacterial agents selected from Augmentin, etc. The essential problem of how to modulate and maintain vaginal flora and vaginal acidity to normal status, however, is not considered in the art. The treatment methods and medicines for killing pathogens have a lot of drawbacks, such as aggravating the abnormality of vaginal flora and vaginal acidity, therefore, make the conditions be complex, recurrent, and so on.
In Chinese invention patents ZL98809508.4 and ZL98809507.6, and U.S. Pat. No. 6,632,796 and U.S. Pat. No. 6,440,949, the inventors of the present invention had disclosed a composition comprising saccharides as effective component for promoting the growth of vaginal Gram-positive rods and increasing vaginal acidity and uses thereof. The problem of how to promote the growth of vagina lactobacilli was well solved by the compositions and uses in these inventions. The vaginal acidity can be effectively elevated and the pH value of vaginal secretion can be decreased. Thus the reduction of large Gram-positive bacilli and the acidity in vagina, the bacterial vaginosis, and vaginal dysbacteriosis could be treated. However, Lactobacillosis and Cytolytic vaginosis as well as Candidal vaginitis, which are related to the over-production of acids by vaginal lactobacilli and the excessive vaginal acidity, cannot be treated.